It’s a tenuous link, perhaps, but for me the common theme is that Medicines and Personal Data are both about to be subject to new regulatory controls. And both will impact businesses in ways that are not widely understood.

We sometimes take regulatory changes for granted, and assume negligible impact in the way we manage our businesses and our customers. Medicines and Personal Data are two that I have recently come across: specifically, the Falsified Medicines Directive and GDPR (General Data Protection Regulations). I believe people need to get these on their radars.

GDPR will affect every company, large or small, and touches down in May 2018

The Falsified Medicines Directive is healthcare specific, but interestingly has a consumer angle as well. It comes into force on 9th February 2019.

GDPR

I thank my colleague Matt Anslow for bringing this to my attention during a recent coaching session. Matt is a Data Protection expert.

This new regulation specifies how personal data may be used, stored and processed. It revisits consumer and employee rights. In short, wherever data is held, consumers and employees can make access requests. This will present real challenges to IT professionals and infrastructures.

It will also be a real challenge for business models, as we’ve become accustomed to the free flow of personal data in order to shape customer experiences and create strategic programmes to engender customer loyalty. And don’t forget the role that trust plays in the context of consumers and employees holding personal data; we’ve witnessed a few high-profile cases recently where data has been compromised and trust has instantly gone out the window.

However, there are upsides: the regulations can facilitate a great experience for consumers and employees once compliance is in place. Seeking professional expertise to achieve that compliance may not be a bad idea.

Falsified Medicines Directive

I have myself to thank for this as pharma in general, and falsified medicines in particular, are areas of my personal expertise.

The new directive is a mandate for pharmaceutical supply chain stakeholders. Its remit is to strengthen aspects of the supply chain through the introduction of a unique identifier. This will enable the identification of individual packs of prescription medicines and introduce specific safety features for outer packaging. The core objective is patient safety.

These features, particularly the unique identifier, will be monitored through a new medicines verification system with the legislation coming into force from the 9th February 2019.

This may be an EU directive but be in no doubt that the UK regulatory authorities will also expect and ensure UK compliance. It affects the entire pharmaceutical supply chain, from the molecule providers through to the dispensers.

I’m sure those of you involved in healthcare are aware of this. But, keeping in mind the core reason for its introduction being ‘patient safety’, my only caution is this: do you know to what extent will it impact upon you? I’m happy to advise on the implications to specific businesses in the pharma supply chain.

Gary has significant commercial experience gained with FMCG companies such as Diageo, Reckitt Benckiser, GSK, Unilever and Cadburys. He has also held senior positions within the healthcare sector both in the UK (AAH Pharmaceuticals) and in Germany (Celesio AG).